Cross-linked and Non-cross-linked Hyaluronic Acid in Subdeltoid Bursitis

Taipei Medical University

Status and phase: Not yet enrolling; Phase 4

Conditions: Subdeltoid Bursitis; Hyaluronic Acid

Treatments: Drug: cross-linked hyaluronic acid; Drug: non-cross-linked hyaluronic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT06508125

2024SKHADR036

Details and patient eligibility

About

This study aims to compare the efficacy of different structures of hyaluronic acid, namely cross-linked and non-cross-linked hyaluronic acid, in treating subdeltoid bursitis.

Full description

A double-blind, randomized clinical trial will be conducted to collect 52 patients with subdeltoid bursitis. The patients will be injected with cross-linked or non-cross-linked hyaluronic acid under ultrasound guidance. Before treatment, one week after treatment (i.e., one week after injection), one month after treatment, and three months after treatment to detect shoulder pain (visual analog scale; pressure ergometer to measure pain pressure threshold), function (including Disabilities of the Arm, Shoulder, and Hand: DASH and Shoulder Pain and Disability Index: SPADI), quality of life (Brief version of the World Health Organization Quality of Life Scale: WHOQOL-BREF) will be arranged.

Enrollment: 52 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• clinical diagnosis of subdeltoid bursitis
• age 20 or older 20
• at least one positive in the painful arc, neer test, or Hawkins test
• can attend three months of intervention and follow-up

Exclusion criteria

• history of malignancy
• previous shoulder operation or injury
• previous shoulder injections in the past three months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

52 participants in 2 patient groups

cross-linked hyaluronic acid group

Experimental group

Description:

cross-linked hyaluronic acid injection, one-time, plus physical therapy

Treatment:

Drug: cross-linked hyaluronic acid

non-cross-linked hyaluronic acid group

Active Comparator group

Description:

non-cross-linked hyaluronic acid injection, one-time, plus physical therapy

Treatment:

Drug: non-cross-linked hyaluronic acid